Propafenone HCl

Orange BookUNIISPLATC C01BC03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeC01BC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0591058201
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0582-01)

Annotations

UNII (FDA Substance ID)

33XCH0HOCD

PROPAFENONE HYDROCHLORIDE

RxCUI 203135

Orange Book

A075203

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "33XCH0HOCD",
    "rxcui": "203135",
    "inchikey": "XWIHRGFIPXWGEF-UHFFFAOYSA-N",
    "display_name": "PROPAFENONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c65253ab-937f-4982-b841-69c2b9f9ccdb": {
      "match": "brand_token",
      "title": "PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "3",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0591-0582_2e5ad1da-4d1b-4ebc-a9af-6d4d7d1cc97d",
  "productndc": "0591-0582",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075203",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Oct 24, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "002",
        "approval_date": "Oct 24, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPAFENONE HYDROCHLORIDE",
  "proprietary_name": "Propafenone HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075203",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Propafenone hydrochloride",
  "start_marketing_date": "20001024",
  "active_numerator_strength": "150"
}

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